510(k) · Cleared
Recalled · 2006Terumo Khuri Myocardial PH Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Cardiovascular Systems Corp. · CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Cleared on Jun 20, 2002 as substantially equivalent to K862114 (Vascular Technology Incorporated, 1986) after an 87-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 20, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- CBZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862114 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK862114 Khuri Regional Tissue PH MonitorVascular Technology Incorporated · 1986
- This deviceK020967 Terumo Khuri Myocardial PH Monitoring SystemTerumo Cardiovascular Systems Corp. · 2002
- Descendant · cites it directly · 2 of its ownK130079 Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK133923 Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK141496 Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K130079Multi-Parameter Mobile Careguide 3100 OximeterReflectance Medical, Inc. · 2013 · cites it directly2descendants
- K133923Multi-Parameter Mobile Careguide 3100 Oximeter with TabletReflectance Medical, Inc. · 2014 · 2 generations on1descendant
- K141496Multi-Parameter Mobile Careguide 4100 OximeterReflectance Medical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862114 | Khuri Regional Tissue PH Monitor | Vascular Technology Incorporated | 1986 | — |
| 0 (this device) | K020967 | Terumo Khuri Myocardial PH Monitoring System | Terumo Cardiovascular Systems Corp. | 2002 | — |
| +1 | K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | Reflectance Medical, Inc. | 2013 | — |
| +2 | K133923 | Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet | Reflectance Medical, Inc. | 2014 | — |
| +2 | K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | Reflectance Medical, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CBZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K862114 | Khuri Regional Tissue PH MonitorSummary page 1…rade Name: Terumo KhuriTMMyocardial pH Monitoring System Device Classification Name: Indwelling Blood Hydrogen Ion conc ion (pH) analyzer (21 Predicate Devices: K862 114 Khuri Regional Tissue pH Monitor Device Description: The Terumo KhuriTMMyocardial pH Monitoring System (Khuri MpH syste… | 1986 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130079 | Multi-Parameter Mobile Careguide 3100 Oximeter | 2013 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2006 | Not classified | Z-1517-06 | Other | Lack of Assurance of Sterility: these specific lots of sensors lack supporting documentation for sterilization assurance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K130079 (Reflectance Medical, Inc., 2013) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CBZ devicesCBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBZ
FDA has decided no CBZ device since 2007.
Median 510(k) review, days · CBZ
Too few CBZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CBZ
No recall names CBZ since 2007.
Adverse event reports per year · CBZ
1in 2024
MAUDE reports naming product code CBZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Terumo KhuriTMMyocardial pH Monitoring System is intended for use in monitoring local tissue pH and temperature, typically during procedures in which specific tissues may be subjected to conditions which may result in ischemia, such as the myocardium, during cardiac operations. These parameters are displayed at 37°C corrected value. For documentation purposes, the integral printer provides a hard copy of displayed parameter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020967 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020967: Terumo Khuri Myocardial PH Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020967
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026